Ignite Creation Date:
2024-05-06 @ 2:40 PM
Last Modification Date:
2024-10-26 @ 1:35 PM
Study NCT ID:
NCT04390243
Status:
TERMINATED
Last Update Posted:
2024-05-06
First Post:
2020-05-12
Brief Title:
Binimetinib and Encorafenib for the Treatment of Pancreatic Cancer in Patients With a Somatic BRAF V600E Mutation
Sponsor:
Academic and Community Cancer Research United
Organization:
Academic and Community Cancer Research United
Study Overview
Official Title:
BrafPanc A Phase II Trial of Binimetinib in Combination With Encorafenib in Patients With Pancreatic Malignancies and a Somatic BRAFV600E Mutation
Status:
TERMINATED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial studies the side effects and how well the combination of binimetinib and encorafenib work in treating patients with pancreatic cancer with a somatic BRAF V600E mutation Binimetinib and encorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Giving binimetinib and encorafenib may work better compared to the usual treatment in treating patients with pancreatic cancer and a somatic BRAF V600E mutation
Detailed Description:
PRIMARY OBJECTIVE
I To determine the efficacy of the combination of binimetinib and encorafenib as 2nd line of treatment for patients with metastatic pancreatic cancer with BRAF V600E mutation
SECONDARY OBJECTIVES
I To determine in patients treated with the combination of binimetinib and encorafenib as 2nd line of treatment for patients with metastatic pancreatic cancer with BRAF V600E mutation
Ia The median progression-free survival Ib The median overall survival Ic Duration of response Id Time to response Ie The safety and tolerability
OUTLINE
Patients receive encorafenib orally PO once daily QD and binimetinib PO twice daily BID on days 1-25 Treatment repeats every 28 days for up to 36 cycles in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for up to 5 years
I To determine the efficacy of the combination of binimetinib and encorafenib as 2nd line of treatment for patients with metastatic pancreatic cancer with BRAF V600E mutation
SECONDARY OBJECTIVES
I To determine in patients treated with the combination of binimetinib and encorafenib as 2nd line of treatment for patients with metastatic pancreatic cancer with BRAF V600E mutation
Ia The median progression-free survival Ib The median overall survival Ic Duration of response Id Time to response Ie The safety and tolerability
OUTLINE
Patients receive encorafenib orally PO once daily QD and binimetinib PO twice daily BID on days 1-25 Treatment repeats every 28 days for up to 36 cycles in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for up to 5 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA015083 | NIH | Academic and Community Cancer Research United | httpsreporternihgovquickSearchP30CA015083 |
| NCI-2020-02972 | REGISTRY | None | None |
| ACCRU-GI- 1907 | OTHER | None | None |